NCT04832607: TRACE

Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial

Recruiting now Phase 3 Last updated 15 July 2025

What this trial tests

Phase 3 trial testing Multivirus (CMV, EBV, AdV)-specific T cells in AdV Infection in 149 participants. Currently enrolling.

Timeline

27 August 2019

Primary endpoint
1 March 2028

1 September 2028

Quick facts

Lead sponsor	Tobias Feuchtinger
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	149
Start date	27 August 2019
Primary completion	1 March 2028
Estimated completion	1 September 2028
Sites	33 locations across Belgium, France, Germany, Italy, Netherlands, Spain

Drugs / interventions tested

• Multivirus (CMV, EBV, AdV)-specific T cells

Conditions studied

• AdV Infection — all drugs for AdV Infection →
• EBV Infection — all drugs for EBV Infection →
• CMV Infection — all drugs for CMV Infection →
• Stem Cell Transplant Complications — all drugs for Stem Cell Transplant Complications →

Sponsor

Tobias Feuchtinger

Who can join

2 Months and older, any sex, with AdV Infection or EBV Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Viral clearance
  Time frame: 8 weeks after treatment
  Percentage of patients with viral clearance (defined as two consecutive negative PCRs) to determine efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation
• Disease Progression
  Time frame: day 7 until week 8 after treatment
  Percentage of patients with progression between Day 7 and Week 8 after T-cell Transfer to determine efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation

Sponsor's own description

Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CMV Infection and CMV-Specific Immune Reconstitution Following Haploidentical Stem Cell Transplantation: An Update.
   Luo XH, Zhu Y, Chen YT, Shui LP, et al · · 2021 · cited 21× · PMID 34777342 · DOI 10.3389/fimmu.2021.732826
2. Adoptive Immunotherapy for Prophylaxis and Treatment of Cytomegalovirus Infection.
   Ouellette CP. · · 2022 · cited 17× · PMID 36366468 · DOI 10.3390/v14112370
3. Pathogen-specific T Cells: Targeting Old Enemies and New Invaders in Transplantation and Beyond.
   Papadopoulou A, Alvanou M, Karavalakis G, Tzannou I, et al · · 2023 · cited 11× · PMID 36698615 · DOI 10.1097/hs9.0000000000000809
4. EBV Reactivation and Disease in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients and Its Impact on HSCT Outcomes.
   Law N, Logan C, Taplitz R. · · 2024 · cited 10× · PMID 39205268 · DOI 10.3390/v16081294
5. Stem cell memory EBV-specific T cells control EBV tumor growth and persist in vivo.
   Palianina D, Mietz J, Stühler C, Arnold B, et al · · 2024 · cited 8× · PMID 39178248 · DOI 10.1126/sciadv.ado2048
6. Virus-Specific T-Cell Therapy for the Management of Viral Infections in the Immunocompromised.
   Koukoulias K, Papayanni PG, Leen AM, Vasileiou S. · · 2025 · cited 3× · PMID 39944414 · DOI 10.1159/000540961
7. In-situ scalable manufacturing of Epstein-Barr virus-specific T-cells using bioreactor with an expandable culture area (BECA).
   Chen S, Bin Abdul Rahim AA, Wang WW, Cheong R, et al · · 2022 · cited 2× · PMID 35487951 · DOI 10.1038/s41598-022-11015-z
8. Modified T cells as therapeutic agents.
   Singh N. · · 2021 · cited 2× · PMID 34889384 · DOI 10.1182/hematology.2021000262